The Recall Desk
SevereFDA (Devices)·Z-0896-2013·Announced 2013-03-06

Orthofix Firebird Spinal Fixation System Rod Connectors Recalled for Cracking Risk

Orthofix is recalling Firebird Spinal Fixation System rod connectors because a sub-component may crack during tightening.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a spinal fixation device, which meets the rubric criteria for a Severe rating.

Plain-English summary

Orthofix, Inc. is recalling the Firebird Spinal Fixation System, specifically the Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). The recall involves 565 total units, consisting of 287 Parallel Rod Connectors and 278 Axial Rod Connectors.

The recall is due to a possibility that the Set Screw (p/n 90-2923) sub-component may crack during final tightening. Orthofix received six customer complaints related to set screw cracking between November 15, 2010, and December 2012.

The affected products were distributed worldwide, including the United States (nationwide and Puerto Rico), Australia, Lebanon, Germany, Spain, Sweden, and Israel. All lot numbers are affected. The FDA has classified this as a Class II recall.

The recalled product

Product
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a lo
Manufacturer
Orthofix, Inc
Category
Medical Device — Orthopedic / Spinal
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog Numbers: 52-6800 & 52-6700
  • All Lot Numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Orthofix, Inc

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Same hazard · structural failure

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